(US-Massachusetts) Do you have 5-10 years of Clinical Development experience in a CRO or biopharmaceutical company? Do you have a PharmD or a Phd? Have you experience in the therapeutic area of Diabetes? If so – Read on. An opportunity exists to join a rapidly expanding, financially stable company in the New England area. Your track record of success in leading clinical programs will now provide you with the opportunity to develop and implement early clinical development programs to include the clinical pharmacology component. Your experience will allow you to manage this early clinical stage product through the clinical/regulatory process and into approval. You will be the recognized expert in all clinical pharmacology issues/questions. Your qualifications must be a PhD / PharmD with significant experience in a clinical pharmacology related discipline. Global project management experience is a must as well as budgetary/financial responsibilities. A track record of leading a pharmaceutical development is a necessity.
(US-New York-Rochester) My client is an international pharmaceutical company with a substantial long-term commitment to innovative drug discovery and development. The company has an extensive product pipeline providing excellent prospects for sustained future growth and is in the unique position of being both an R&D intensive company with several current products on the market. Current core product areas include autoimmune and inflammatory disorder products, as well as cancer products. The company is in the process of developing a new GI product, and the Director, MSL position is being created to prepare for the upcoming launch of the product. Both the products and business unit are new to the company, with important opportunities to further build and develop their role in the future. This position will report directly to the Senior Vice President of Medical & Regulatory Affairs, and will eventually lead a team of region-based medical scientific liaisons in the U.S. This is a director-level position that will develop and lead the MSL function for the gastroenterology portfolio and be a member of the senior staff. The Director will be both internally and externally focused, having significant and frequent collaboration with the GI Business Unit. The successful applicant will initially be responsible for developing and maintaining relationships with influential members of the GI community in the U.S. The position will provide significant input into the development of brand strategies, product positioning, key messages, data review, and future data needs. A full job description is available to qualified and interested candidates. My client is prepared to relocate qualified applicants from any state in the U.S. Requirements: * PharmD, PhD, or M.D. degree with a strong interest in IBD. * 3-5 years of previous pharmaceutical industry experience in clinical and/or medical information environment. * Proven accomplishment in portfolio-based medical scientific liaison activity. * Specific Gastroenterology experience highly preferred, but not required. * Commercial orientation and aptitude to understand the business drivers in key pharmaceutical markets. * Excellent presentation, writing, and one-on-one communication skills. * A team player with the ability to interact effectively with customers, colleagues, and commercial teams. * Ability to effectively communicate complex medical scientific information to physicians, health care professionals, patients, and non-physicians. * Thorough understanding of federal regulations relating to drug promotion, clinical trials, and dissemination of medical information. * Previous leadership and/or managerial experience preferred, but not required. * Ability and willingness to travel frequently to both domestic and international locations as needed
(US-New York-Rochester) My client is an international pharmaceutical company with a substantial long-term commitment to innovative drug discovery and development. The company has an extensive product pipeline providing excellent prospects for sustained future growth and is in the unique position of being both an R&D intensive company with several current products on the market. Core product areas include autoimmune and inflammatory disorder products, as well as cancer products. The position of Director of Medical Affairs is a new position, resulting from the need to strengthen the management capabilities within the Medical Affairs department. The position will report directly to the Senior Vice President of Medical & Regulatory Affairs, and will manage 8 others including medical education & communications, medical information, and administrative staff. The Director of Medical Affairs will be responsible for managing all medical information, education, and communication activities pertaining to assigned products/therapeutic areas, providing medical expertise and making decisions relevant to the scientific support of the products. The role has the overall responsibility to plan and implement medical affairs strategies, policies, standards and resources consistent with the needs of the US commercial organizations and to provide support for projects as required. Complete job description available for qualified and interested candidates. My client is prepared to relocate the successful applicant from any state in the US. Base salary will depend on experience, with up to 25% in bonus potential. See below for specific background requirements for candidates. Requirements: * M.D., PhD (Life Science discipline), or PharmD required. * 5-10 years medical affairs and/or clinical research experience in the pharmaceutical and/or biotechnology industry required. * 3-5 years previous managerial experience (both people and projects). * Thorough knowledge of regulations relevant to medical, labeling, drug development, and drug promotion activities. * Proven strong leadership and professional expertise in development and implementation of sound Medical Affairs strategies. * Strong analytical, planning, and execution skills with the ability to develop a vision and lead change. * Ability to apply creative strategies to expedite business objectives. * Excellent medical/technical written and oral communication skills. * Ability to discuss scientific/technical data with senior management in both a classic line function and matrixed environment. * Basic proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.) as evidenced by the ability to create correspondence, analyze and report data, prepare presentations, communicate electronically and research information. * Ability to travel as needed.
(US-New Jersey) This is technical position with heavy managerial responsibilities. The incumbent is responsible for the delivery of every aspects of statistical support to clinical development, registration, and marketing of new drugs. This is a highly independent position sustained by the training, experience, and judgment of the incumbent. Activities are to be coordinated with project priorities, and project team decisions. But this incumbent is the technical leader in all aspects of biostatisitics. The scope of responsibility includes all clinical programs. PRINCIPAL ACCOUNTABILITIES: RESOURCE MANAGEMENT Workload management including prioritization, task assignment, timeline management, and outsourcing management. HR issues, including performance evaluation, hiring, termination. Manage the interactions with headquarters statistical group. CUSTOMER MANAGEMENT Manage the relations with the regulatory agencies (primarily the FDA). Manage the relations with internal customers, including clinicians, medical writers, and marketing managers, as well as the similar functions at the headquarters. CLINICAL TRIAL DESIGN AND ANALYSIS Guide department staff proactively participate in clinical development projects. Assure that statistical and scientific methodologies are fully considered and documented. Guide and participate the review of study protocols, critic and suggest improvement on scientific methodology, write statistical sections, develop plans for statistical analysis and presentation. Guide the interaction with medical development, medical writing, regulatory affair, and regulatory agencies. Assure statistical input, analysis, and reports of the highest quality are delivered according to schedule. STATISTICAL PROGRAMMING AND PRESENTATION Work through data management, assure that data listing, tables, and graphs are produced with highest efficiency and quality. Provide input to the development and maintenance of statistical routine libraries. Assure efficient use of resources and talents. QUALITY AND PROCEDURE IMPROVEMENT Participate in the development and update of internal SOPs and working procedures. Lead department staff keeping abreast with current statistical literature. Assure the most current regulatory requirements are followed and sound methodologies are adopted. Keeping abreast and observe general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, SOPs, and generally accepted GCP. JOB REQUIREMENTS: Advanced degree in Biostatistics, Statistics, or relevant areas (Ph.D. preferred). At least 10 years of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility. Extensive knowledge of statistical concepts and techniques and of clinical trial principles. Extensive knowledge of regulatory requirement. Excellent communication, interpersonal and organization skills. Excellent leadership skill.
(US-Florida) Project development; Generating protocols; Develop the program to study the drug; Develop the research; Analyze the data and summarize for FDA submission; 5+ years related vet pharma experience required. Type of Position: Full-Time Permanent Starting Date: ASAP Annual Salary and Bonus: 100k + bonus Education Required: Doctoral
